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Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever

NCT02116205 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-02-12

Study results available
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Summary

The purpose of this study is to compare the immune responses of two different doses (1.0 mg and 2.0 mg) and two different dosing schedules (two doses or three doses) of a mixed Hantaan virus (HTNV) and Puumala virus (PUUV) DNA vaccine in healthy participants. To maintain a blind, participants in the two-dose group will receive one dose of normal saline placebo. All of the groups will also receive a booster dose 6 months after first vaccination. The results will help to determine which dose and vaccination schedule will be best to move forward in the vaccine development process.

Conditions

  • Hemorrhagic Fever With Renal Syndrome

Interventions

BIOLOGICAL

HTNV/PUUV DNA vaccine

HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)

BIOLOGICAL

Placebo

0.9% sodium chloride

DEVICE

TriGrid Delivery System (TDS)

The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses

Sponsors & Collaborators

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • Ichor Medical Systems Incorporated

    collaborator INDUSTRY

  • United States Army Medical Materiel Development Activity

    collaborator FED

  • US Army Medical Research Institute of Infectious Diseases

    collaborator FED

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Kristopher Paolino, MD · WRAIR Clinical Trials Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-09
Primary Completion
2016-12-07
Completion
2017-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02116205 on ClinicalTrials.gov